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Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00783094
First received: October 30, 2008
Last updated: March 18, 2011
Last verified: March 2011
History of Changes
Results First Received: June 25, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Benign Prostatic Hyperplasia
Interventions: Drug: Tadalafil 2.5 mg
Drug: Tadalafil 5 mg
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Tadalafil 2.5 mg 2.5 milligrams (mg) tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Tadalafil 5 mg 5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.
Placebo

Placebo tablet taken by mouth once a day for 12 weeks.

Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.

Participant Flow for 2 periods

 Period 1:   Randomized Double-Blind Treatment Period
    Tadalafil 2.5 mg     Tadalafil 5 mg     Placebo  
STARTED     142     140     140  
COMPLETED     135     128     131  
NOT COMPLETED     7     12     9  
Adverse Event                 4                 5                 5  
Lack of Efficacy                 0                 2                 1  
Physician Decision                 0                 2                 0  
Protocol Violation                 1                 2                 1  
Withdrawal by Subject                 2                 1                 2  

Period 2:   Open-Label Extension Period
    Tadalafil 2.5 mg     Tadalafil 5 mg     Placebo  
STARTED     135     128     131  
COMPLETED     113     109     101  
NOT COMPLETED     22     19     30  
Adverse Event                 12                 7                 16  
Death                 0                 0                 1  
Protocol Violation                 4                 5                 7  
Withdrawal by Subject                 1                 1                 3  
Physician Decision                 4                 2                 3  
Lack of Efficacy                 1                 4                 0  



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint   [ Time Frame: Baseline, 12 weeks ]
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5.  Secondary:   Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 6

7.  Secondary:   Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement   [ Time Frame: Baseline, 12 weeks ]
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8.  Secondary:   Number of Participants With Adverse Events During 12 Weeks of the Study   [ Time Frame: Baseline through 12 weeks ]
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9.  Secondary:   Change From Baseline in Blood Pressure at 12-Week Endpoint   [ Time Frame: Baseline, 12 weeks ]
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10.  Secondary:   Change From Baseline in Sitting Heart Rate at 12-Week Endpoint   [ Time Frame: Baseline, 12 Weeks ]
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11.  Secondary:   Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 11

12.  Secondary:   Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint   [ Time Frame: Baseline, 12 weeks ]
  Show Outcome Measure 12

13.  Secondary:   Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint   [ Time Frame: Baseline, 54 weeks ]
  Show Outcome Measure 13

14.  Secondary:   Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint   [ Time Frame: Baseline, 54 weeks ]
  Show Outcome Measure 14

15.  Secondary:   Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint   [ Time Frame: Baseline, 54 weeks ]
  Show Outcome Measure 15

16.  Secondary:   Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint   [ Time Frame: Baseline, 54 weeks ]
  Show Outcome Measure 16

17.  Secondary:   Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint   [ Time Frame: Baseline, 54 weeks ]
  Show Outcome Measure 17

18.  Secondary:   Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint   [ Time Frame: Baseline, 54 weeks ]
  Show Outcome Measure 18

19.  Secondary:   Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment   [ Time Frame: End of 12 weeks of double-blind through 54 weeks ]
  Show Outcome Measure 19

20.  Secondary:   Change From Baseline in Blood Pressure During at 54-Week Endpoint   [ Time Frame: Baseline, 54 weeks ]
  Show Outcome Measure 20

21.  Secondary:   Change From Baseline in Sitting Heart Rate at 54-Week Endpoint   [ Time Frame: Baseline, 54-weeks ]
  Show Outcome Measure 21

22.  Secondary:   Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint   [ Time Frame: Baseline, 54 weeks ]
  Show Outcome Measure 22

23.  Secondary:   Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint   [ Time Frame: Baseline, 54 weeks ]
  Show Outcome Measure 23


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00783094     History of Changes
Other Study ID Numbers: 12757, H6D-JE-LVIA
Study First Received: October 30, 2008
Results First Received: June 25, 2010
Last Updated: March 18, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency